Optimizing Mealtime Care (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents With Alzheimer's Disease and Related Dementias (ADRD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice
研究概览
简要总结
The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies.
详细描述
This study developed and refined OPTIMAL, and evaluated its feasibility, fidelity, and usefulness. We used mixed methods (i.e., focus groups, a pilot single-group repeated measures) to refine and test OPTIMAL. We collected repeated measures at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3). At each time point, we assessed quality of staff engagement and resident outcomes including eating performance and BMI through collection and coding of videotaped observations of dyadic mealtime interaction (videos; Aim 2&3) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. We used Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, and assessed resident mealtime challenging behaviors including resistive behaviors and functional impairments and intake success rate using videos collected in this study.11, 25
The specific aims are:
- Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. We will integrate evidence from literature and our prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. We will conduct separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing.
- Determine feasibility, fidelity, and usefulness of OPTIMAL. Feasibility on participant identification, recruitment, consent, and retention will be evaluated descriptively. Fidelity will be assessed on a) delivery of treatment (staff attendance to training sessions), b) receipt of treatment (staff knowledge and self-efficacy pre- & post-training), and c) enactment of treatment skills (staff PCMC&TCMC behaviors, quality of staff engagement). We will conduct focus group interviews of staff to assess the usefulness of OPTIMAL after T3.
- Describe resident outcomes (Exploratory). We will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics over time for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Because this study is a single-group design, all participants were recruited from the nursing home site that was assigned as the intervention group. no one is blinded to the intervention assignment, but all participants and outcome assessors were blinded for the research questions/aims.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 55 years
- •Diagnosed as having ADRD based on medical records
- •Identified by NH staff as requiring mealtime assistance
- •Having a legally authorized representative (LAR) providing informed written consent
- •≥18 years
- •English speaking
- •A permanent facility employee
- •Provide direct mealtime care for a resident participant at least twice a week over the previous month
- •≥18 years
- •English speaking
- •A family member of the resident who is living at the NH study site at the time of the study
- •Having experience of delivering mealtime care to their resident family members
排除标准
- •Have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing disorder,
- •Do not eat orally (e.g., parenteral/IV feedings, feeding tubes)
- •Unable to hear or see staff even with glasses and/or hearing aids (e.g., uncorrected visual or hearing impairment)
- •Stay in the NH study site for less than 12 weeks at the time of recruitment/consent/assent (e.g., terminally ill receiving hospice services, and/or receiving post-hospital skilled rehabilitation) that may not allow enough time for obtaining consent/assent, and scheduling days for video recording sessions across three-time points (baseline, and 6- and 12- weeks post-baseline)
结局指标
主要结局
Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice
时间窗: After recruitment of staff participants and before T1 (baseline)
All staff participants were interviewed on whether the intervention protocol and training materials were acceptable and appropriate for nursing home mealtime care practice before pilot testing.
The Number of Staff Participants Who Attended All Training Sessions
时间窗: During each OPTIMAL training session (within 2 weeks post baseline)
A checklist was used to track the number of staff participants who attended all the group and/or individual training sessions that were provided in the study.
Number of Staff Participants Who Viewed the Intervention Was Useful
时间窗: After T3 data collection time point (12-weeks post baseline)
All staff participants were interviewed on whether the intervention was useful post testing. The number of staff participants who viewed the intervention was useful was collected.
The Number of Mealtime Difficulty Behaviors Observed in Residents
时间窗: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Videos will be coded using the Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme that have codes for resident mealtime difficulties including 1) resistive behaviors and 2) functional impairments. we recorded the number of behaviors representing mealtime difficulties presented by residents, the higher the number, the worse the outcome.
Number of Staff and Resident Participants Recruited and Retained for the Study
时间窗: From recruitment/consent throughout the study completion, up to 12-weeks post baseline
The number of staff and resident participants that were recruited at baseline and retained over the study period were collected to indicate the feasibility of the study on participant recruitment, consent and retention.
Staff Person-centered Care Knowledge and Self-efficacy
时间窗: Right before and after OPTIMAL training session (within 2 weeks post baseline)
Training receipt, indicated by a total score of ≥ 75% on the staff PCMC-related knowledge \& self-efficacy test post-training with or without booster sessions. The total score of the scale ranges from 0 - 20, and higher scores are better. we recorded the number of staff who reached this cutoff score post training.
Resident Level of Eating Performance
时间窗: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Level of Eating Independence Scale, a 9-item scale assessing the ability of independence with eating and drinking activities during cycles of verbal prompts, will be used to measure. Each item is scored from 1 (total dependence) to 4 (total independence), with total score ranging from 9 to 36 (higher score = more independence).
Resident Intake Success Rate
时间窗: T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)
Videos will be coded using CUED to track whether the resident or staff initiates/completes each intake attempt and whether there is a subsequent intake after each attempt. Resident intake success rate will be calculated by dividing the number of intake attempts initiated/completed by the resident with subsequent intake by the total number of intake attempts coded during one meal. the percent can range from 0 - 100%, the higher the number, the more independent the resident.
次要结局
- Resident Body Mass Index (BMI).(T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline))
- Quality of Staff Engagement(T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline))
研究者
Wen Liu
Associate Professor
University of Iowa